Cleared Traditional

KATANA Zirconia

K143439 · Kuraray Noritake Dental, Inc. · Dental
Feb 2015
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K143439 is an FDA 510(k) clearance for the KATANA Zirconia, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Kuraray Noritake Dental, Inc. (Chiyoda Ku, JP). The FDA issued a Cleared decision on February 27, 2015, 87 days after receiving the submission on December 2, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K143439 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2014
Decision Date February 27, 2015
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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